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PHENYTOIN SODIUM 50MG/ML SOLUTION FOR INJECTION

Active substance(s): PHENYTOIN SODIUM / PHENYTOIN SODIUM / PHENYTOIN SODIUM

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notice format 127x500:NOTICE FORMAT 500X127

15/11/07

11:24

Page 1

127 mm

5038207

PACKAGE LEAFLET: INFORMATION FOR THE USER

Phenytoin Sodium 50mg/ml
Solution for Injection
Read all of this leaflet carefully before you start using this medicine because
it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Phenytoin Sodium 50mg/ml Solution for Injection. It will
be referred to as Phenytoin Injection for ease hereafter.
What is in this leaflet:
1. What Phenytoin Injection is and what it is used for
2. What you need to know before you use Phenytoin Injection
3. How to use Phenytoin Injection
4. Possible side effects
5. How to store Phenytoin Injection
6. Contents of the pack and other information
1. WHAT PHENYTOIN INJECTION IS AND WHAT IT IS USED FOR
Phenytoin belongs to a group of drugs known as hydantoins. It is called an
anticonvulsant because it works by controlling the overactivity in the brain that can
cause epilepsy or seizures (fits).
Phenytoin Injection is used to:
• Control epileptic fits involving jerking and spasm of the muscles (known as grand
mal fits)
• Prevent and treat fits resulting from brain surgery or head injury.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE

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PHENYTOIN INJECTION
Do not use Phenytoin Injection, if you:
• know that you have an allergy to phenytoin or to any of the other ingredients in the
formulation (listed in section 6) or to any other hydantoin drug (such as ethotoin or
methoin)
• have a slow heart beat or heart problems that interfere with the rate at which your
heart beats
• Adams-Stokes syndrome.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Phenytoin Injection if you:
• have low blood pressure or disease of the heart muscle
• have a disease of the liver or kidneys
• have diabetes
• have porphyria (an inherited condition affecting the nervous system and skin,
characterised by abdominal pain, vomiting or muscle weakness)
• have drank a large amount of alcohol recently or if you drink large amounts of alcohol
regularly or if you have alcohol dependence
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of Phenytoin sodium, appearing initially
as reddish target-like spots or circular patches often with central blisters on the trunk
• additional signs to look for include ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes)
• these potentially life-threatening skin rashes are often accompanied by flu-like
symptoms. The rash may progress to widespread blistering or peeling of the skin
• the highest risk for occurrence of serious skin reactions is within the first weeks of
treatment
• if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the
use of Phenytoin sodium, you must not be re-started on Phenytoin sodium at any time
• if you develop a rash or these skin symptoms, seek immediate advice from a doctor
and tell that you are taking this medicine.
A small number of people being treated with anti-epileptics such as Phenytoin have
had thoughts of harming or killing themselves, if at any time you have these thoughts,
immediately contact your doctor.
Tell your doctor if any of these apply to you as special care may be needed. Your doctor
will take particular care with this medicine if you are elderly or gravely ill.
Phenytoin may precipitate or aggravate absence seizures and myoclonic seizures (two
specific types of epilepsy).
Other medicines and Phenytoin Injection
A large number of drugs can interact with phenytoin which can significantly alter their
effects.
Tell your doctor or pharmacist if you are using, have recently used or might use any
other medicines. This will allow your doctor to decide whether it is safe for you to be
given phenytoin.
The doctor may want to take a sample of your blood before giving you phenytoin to
test whether any medicine that you are already taking will be affected by phenytoin.
The most common medicines are listed below and include medicines for:
• Epilepsy or fits (e.g. carbamazepine, lamotrigine, phenobarbital, sodium valproate
and valproic acid, ethosuximide, succinimides and vigabatrin)
• Corticosteroids e.g. prednisolone (used in numerous situations to aid the body’s
healing process)
• Fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole and
miconazole)
• Skin diseases (e.g. methoxsalen)
• Tuberculosis and other infections (e.g. chloramphenicol, isoniazid, rifampicin,
sulphonamides, doxycycline and ciprofloxacin)
• Asthma and bronchitis (theophylline)
• Diabetes (e.g. tolbutamide)
• High blood pressure (e.g. calcium channel blockers like diltiazem, felodipine)
• Pain and inflammation (e.g. phenylbutazone, salicylates, azapropazone and steroids)
• Stomach ulcers and heartburn (e.g. omeprazole, sucralfate, the medicines known
as H2 antagonists e.g. cimetidine, some antacids)
• Sleeplessness, depression and psychiatric disorders (e.g. chlordiazepoxide,
clozapine, diazepam, disulfiram, lithium, methadone, fluoxetine, fluvoxamine,
sertraline, haloperidol, levodopa, paroxetine, methylphenidate, phenothiazines,
quetiapine, trazodone, reserpine, tricyclic antidepressants and viloxazine)
• Cancer (fluorouracil, antineoplastic agents)
• Organ and tissue transplants, to prevent rejection (ciclosporin)
• Heart and circulation problems (e.g. dicoumarol, amiodarone, nifedipine, digitoxin,
disopyramide, mexiletine, furosemide and quinidine)
• Hormone replacement therapies (oestrogens) and oral contraceptives
• Thyroid disorders (e.g. thyroxine)
• Some medicines used in operations, e.g. halothane (an anaesthetic) and
neuromuscular blockers (used to relax muscles)
• Some products available without a prescription (folic acid, vitamin D).
Blood test may be necessary every six months to monitor the amount of folic acid in
the blood.
• The herbal remedy St. John’s wort (Hypericum perforatum) should not be taken at
the same time as this medicine. If you have already taken St. John’s wort, consult
your doctor before stopping St. John’s wort preparations
• Anticoagulants, e.g. warfarin (as its effect may be enhanced by phenytoin)
• Drugs used in Human immunodeficiency virus (HIV) infected patients (e.g.
amprenavir, nelfinavir).
Phenytoin Injection with food, drink and alcohol
Speak to your doctor before being given this medicine if you have recently had a drink
of alcohol. Drinking a lot of alcohol can also affect the concentration of Phenytoin in
your blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
Do not stop taking phenytoin until you have seen your doctor as it is important to
control your fits. If given during pregnancy phenytoin may affect the baby but your
doctor may decide that it is very important that you continue with phenytoin. He or she
will explain the risks to you.
As phenytoin is released into breast milk, you should not breast-feed if you are taking
this medicine.
Driving and using machines
Phenytoin may cause dizziness or drowsiness. If you experience these symptoms, do
not drive or use any tools or machinery.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Phenytoin Injection
Propylene glycol, ethanol, sodium hydroxide are all present in this product.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e.
essentially ‘sodium-free’.
This medicinal product contains 10 % vol ethanol (alcohol), i.e. up to 395.75 mg per
dose, equivalent to 7.9ml beer, 3.2ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or
breast-feeding women, children and high-risk groups such as patients with liver disease
or epilepsy.
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3. HOW TO USE PHENYTOIN INJECTION
Phenytoin injection is given by a doctor or nurse. It may be given as an injection slowly
into a muscle or a large vein. Alternatively, it may be diluted and given as a drip or
infusion into one of your large veins (intravenously).
The correct dose will be calculated by your doctor according to your body weight. A
repeat injection may be given after 30 minutes if necessary.
During your treatment your doctor may monitor your blood levels of phenytoin by
taking regular blood samples.
If you think you have been given more Phenytoin Injection than you should have
This is unlikely but if you think that too much of this injection has been administered,
tell your doctor immediately.
If you think you have missed a dose of Phenytoin Injection
If you think that you may have missed a dose, tell your doctor immediately.
If you have any further questions on the use of this product ask your doctor or
pharmacist.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Phenytoin Injection can cause side-effects, although not everybody
gets them.
Important: If you experience any of the following serious side effects contact your
doctor immediately.
• severe allergic reactions such as swelling of the face, tongue and/or throat, which
may cause difficulty in breathing or swallowing
• a skin rash. Your doctor may decide to stop your phenytoin treatment, temporarily
or permanently depending on the type of rash
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section 2). Frequency is very rare
• if you start feeling depressed or have thoughts about suicide
• low white blood cell count
• life threatening irregular heartbeat
• skin discolouration, swelling and pain where the injection was given which then starts
to spread down your arm to your hands and fingers. This may mean you have a
condition known as ‘purple glove syndrome’. In most cases this will improve on its
own but in some cases it can be serious and require urgent medical treatment.
The following side effects have also been reported:
Rare: may affect up to 1 in 1,000 people
• movement disorders including involuntary movements (Dyskinesias), twitching and
repetitive movements or abnormal postures, unsteadiness, difficulty in controlling
movements, shaking, staggering gait, fixed position of the wrist
• drug hypersensitivity syndrome involving severe hypersensitivity reaction , blood cell
count abnormalities (eosinophilia, atypical lymphocytosis), enlarged lymph nodes
and liver dysfunction- DRESS.
Not known: Frequency cannot be estimated from the available data
• skin reactions may also include drug-induced red rash (scarlatiform) or scaling or
blistering of the skin
• slurred speech
• stopping of breathing, formation of scarring and excess fibrous tissue in the lung,
may cause fever, slow or shallow breathing, tiredness, weakness, loss of appetite,
weight loss, chest discomfort
• heartbeat may be too fast or too slow and may be regular or irregular pattern, low
blood pressure which may lead to heart attack
• enlargement of blood vessels. Your blood pressure may also be lowered and
experience heart problems
• unusual eye movements (Nystagmus)
• confusion, drowsiness, dizziness, vertigo (a feeling of dizziness or spinning), difficulty
sleeping
• nervousness (short-lived), headaches and change in taste
• swelling of the lips or gums (occurring more frequently in children and people with
poor oral hygiene)
• abnormal thickening of muscles in the penis (Peyronie’s disease)
• paraethesia: pins and needles or numbness sensation
• purpura: purple rashes on the skin, skin lesions called lupus
• dermatitis bullous – Skin irritation such as peeling of the skin
• purple glove syndrome: drug induced skin injury giving the skin a purple colour
• reduction in blood platelets, which increases risk of bleeding or bruising
(thrombocytopenia)
• severe reduction in all types of blood cells (red, white) and platelets which can cause
weakness, bruising or make infections more likely: Pancytopenia – with or without
bone marrow suppression
• bone disorders including osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic
medication, have a history of osteoporosis or take steroids
• larger than normal red blood cells (macrocytosis), swollen glands (disorder of the
lymph nodes), Hodgkin’s lymphoma (illness of the lymph nodes/glands)
• fits
• liver injury, inflammation of the liver, liver dysfunction
• inflammation of the wall of the arteries and soreness (polyarteritis nodosa), problems
with the body’s defence against infection
• abnormal bruising of the skin
• thickening of the facial features
• feeling sick (nausea), being sick (vomiting), constipation
• allergic reactions: drug hypersensitivity syndrome involving severe hypersensitivity
reaction that includes rash, blood cell count abnormalities (eosinophilia, atypical
lymphocytosis), enlarged lymph nodes (swollen glands) and liver dysfunction
• anaemia (such as paleness or feeling tired)
• irritation, inflammation, pain or injury at the site of injection
• thickening of the facial features, thickening of skin (skin hypertrophy)
• increase in body hair
• a condition which causes inflammation and tissue damage
• a disease of unknown cause that affects arteries, the blood vessels that carry blood
from the heart to organs and tissues
• pain or muscle weakness
• fever, feeling unwell or unusually tired, pains in the joints, sore throat, ulcers
• passing blood in urine or any problem passing urine
• inflammation of kidney tissue (interstitial nephritis)
• damage to the nervous system
• loss of consciousness, seizures, coma, brain death.
Please note that Phenytoin can interfere with some laboratory tests e.g. blood tests,
tests for antibody levels, urine tests. If you are having a test done, remember to mention
that you received treatment with phenytoin.
Please see your doctor if you notice any of these side effects and they cause you
concern or if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE PHENYTOIN INJECTION
Keep this medicine out of the sight and reach of children.
The product should not be used after the expiry date printed on the ampoule (a small
bottle) label and carton, after EXP.
The ampoules should be protected from light and stored at a temperature not greater
than 30°C.
If only part of the contents of an ampoule is used, the remaining solution should be
discarded.
Solutions in which a haziness or precipitate develops should not be used.
The solution should not be mixed with any other drugs.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenytoin Injection contains:
The active substance is phenytoin sodium. Each 1ml of this solution contains 50mg of
phenytoin sodium.
The other ingredients are propylene glycol BP, ethanol BP and sodium hydroxide BP
(as a 10% w/v solution) in water for injections BP.
What Phenytoin Injection looks like and contents of pack:
Phenytoin Injection is a clear, colourless, particle-free solution. Each carton contains
ten 5ml ampoules of Phenytoin Injection.
Marketing authorisation holder:
Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
Manufacturer:
Delpharm Tours, Rue Paul Langevin, 37170 Chambray Les Tours, France.
This leaflet was last revised in April 2017.
LF-102370-01

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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